Senior Statistical Programmer

About the Role

Senior Statistical Programmer is responsible for review of developed SDTM/ADaM mapping specifications.

Responsibilities

• SDTM/ADAM Model and IG - Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG's and related guidelines. Hands on experience in implementing SDTM/ADAM concepts across TA's and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelines.
• Study Reporting - Suggest creative solution approach for various business requirements to solve complex SDTM/ADaM Mapping and Programming problems (e.g. creates modular reusable code, develops standard code or utilities, and designs interconnected programs). Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs). Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan etc. Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA's.
• SAS Programming - Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS and other advanced SAS components. Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.
• Controlled Terminology - Good understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage concepts.
• Other CDISC IGs - Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM. Hands on exposure in managing few of these activities.
• Developing Mapping Specs - Hands on experience in developing mapping specs for SDTM/ADaM. Desirable to have hands on experience in developing mapping specs for a TA or global level SDTM/ADaM mappings.
• SDTM/ADaM Dataset Programming - Hands on experience in generating SDTM/ADaM datasets using SAS programming or other tool-based approach.
• SDTM/ADaM Compliance & Define - Hands on experience generating files, experience in performing SDTM/ADaM compliance checking using P21 or other compliance checks.
• Validation - Implement QA and QC validation in accordance with Departmental SOP's for deliverables including:
• Formal study reports
• Data review
• Presentations
• Adhoc-requests

Qualifications

• At least 5+ years of experience as Sr Statistical Programming
• Completed Degree in Statistic or related or Pharmacy or related
• Must have strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards.
• Clinical working experience is a must.

Required Skills

• Capable to manage communication with customers, track and ensure quality ontime deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time.
• Must have good understanding/exposure in:
• Software development or global macro development process
• Developing user specifications, developing global macros, unit testing
• Experience in handling development and maintenance projects
• Change Management and Version control process
• Clinical guidelines understanding like ICH-GCP, SDTM/ADAM IGs etc.
• Client management, communication, project management and other soft skills

Preferred Skills

• Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM.